MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD¿ POSIFLUSH; VASCULAR CATHETER FLUSH SYRINGE

Catalog Number 306546

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

The initial reporter also notified the fda on (date) via medwatch # 5081661.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a plunger of bd¿ posiflush was difficult to move during use.

Manufacturer Narrative

H.6.Investigation summary: lot number 8192991 was received for evaluation by our quality engineer team.During the production process of lot number 8192991, there was one documented non-conformance that may have contributed to the reported defect.Although a sample was not returned for this specific quality record, defective plunger movement was observed within previous returned samples of the same lot number.During production, a damaged silicone canister was found within the silicone station, which resulted in an insufficient supply of silicone to the syringe barrels.Product associated with this non-conformance was held for inspection and all affected material should have been discarded.It is possible that a misdetection in defective product caused this incident, as the samples were not properly discarded.The damaged silicone canister has since been replaced.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.

Event Description

It was reported that a plunger of bd¿ posiflush was difficult to move during use.

• Brand Name: BD¿ POSIFLUSH
• Type of Device: VASCULAR CATHETER FLUSH SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8199975
• MDR Text Key: 132209395
• Report Number: 9616657-2018-00074
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 306546
• Device Lot Number: 8192991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 12/07/2018
• Supplement Dates FDA Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other